Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis - Full Text View

Purpose

Matrix metalloproteinases have been implicated in the cartilage degradation that occurs in osteoarthritis. PG-530742 inhibits some of these matrix metalloproteinases, thus potentially limiting cartilage degradation and disease progression. This study will test the efficacy and safety of PG-530742 in the treatment of mild to moderate knee osteoarthritis.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: PG-530742 Drug: Placebo tablet, Drug: 50 mg PG-530742 Drug: 100 mg PG-530742 Drug: 200 mg PG-530742	Phase II

MedlinePlus related topics:

Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Safety of PG-530742 in the Treatment of Mild to Moderate Knee Osteoarthritis

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Minimum joint space width in teh medial compartment of the tibiofemoral joint of the knee at one year [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	401
Study Start Date:	January 2002
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablet	Drug: Placebo tablet, One placebo tablet, twice daily for for one year
2: Experimental 25 mg PG-530742	Drug: PG-530742 One 25 mg PG-530742, twice daily for for one year
3: Experimental 50 mg PG-530742	Drug: 50 mg PG-530742 One 50 mg PG-530742, twice daily for for one year
4: Experimental 100 mg PG-530742	Drug: 100 mg PG-530742 100 mg PG-530742 tablet, twice a day for one year
5: Experimental 200 mg PG-530742	Drug: 200 mg PG-530742 200 mg PG-530742 tablet, twice a day for one year

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

mild to moderate knee osteoarthritis confirmed by a radiographic technique.

Exclusion Criteria:

secondary knee osteoarthritis;
diseases other than osteoarthritis that could cause knee pain;
any disease or intervention (surgery, intra-articular injection) that would have an impact on knee pain or mobility;
drugs that act potentially on the bone or cartilage component of the knee joint.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041756

Locations


Hungary
	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology IV., Frankel Leo u. 38-40
	Budapest, Hungary, 1027
	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology and Immunology, Frankel Leo u. 38-40
	Budapest, Hungary, 1027
	National Institute of Rheumatology and Physiotherapy, Dept. of Rheumatology I and Metabolic Osteology, Frankel Leo u. 38-40
	Budapest, Hungary, 1027
	Orthopedic Clinic, Karolina ut 17
	Budapest, Hungary, 1113
	Szent Ferenc Hospital, Department of Rheumatology, Csabai Kapu 42.
	Miskolc, Hungary, 3529

Hungary, Gizella telep
	Rehabilitation Hospital, Gizella telep
	Visegrad, Gizella telep, Hungary, 2026

Hungary, Hid Utica 2
	Petz A. Country Hospital, Department of Rheumatology, Hid utca 2.
	Gyor, Hid Utica 2, Hungary, 9025

United Kingdom
	Dept of Rheumatology Dulwich Hospital, East Dulwich
	London, United Kingdom, SE22 8PT
	Dept of Rheumatology Whipps Cross University Hospital, Whipps Cross Road
	London, United Kingdom, E11 1NR
	Dept of Rheumatology Selly Oak Hospital, Raddleburn Road, Selly Oak
	Birmingham, United Kingdom, B29 6JD
	Rheumatology Department, Fourth Floor, Thomas Guy House, St Guy's House
	London Bridge, United Kingdom, SE1 9RT
	Hildenborough Medical Group, Trenchwood Surgery, 264 Shipbourne Road
	Tonbridge, United Kingdom, TN10 3ET
	Grosvenor Medical Centre Clinical Trials Unit, 18 upper Grosvenor Road, Tunbridge Wells
	Kent, United Kingdom, TN 1 2DX
	Synexus Wrightington, Wrightington Hospital, Hall Lane, Awpley Bridge
	Wigan, United Kingdom, WN6 9EW
	Synexus Birmingham Clinical Research Centre, Birmingham Research Park
	Edgbaston, United Kingdom, B15 2SQ
	Synexus Reading Clinical Research Centre, Whiteley Glebe, 11 Glebe Road, off Christchurch Gardens
	Reading, United Kingdom, RG2 7AG

United Kingdom, Middlesex
	Royal National Orthapaedic Hsopital, Brackley Hill
	Stanmore, Middlesex, United Kingdom, HA 7 4LP
	95 Stanwell Road
	Ashford, Middlesex, United Kingdom, TW15 3EA

United Kingdom, SE17EH
	St Thomas Hospital, Lambeth Place Road
	London, SE17EH, United Kingdom

United Kingdom, Surrey
	The Medical Centre, Kingston Avenue
	East Horsley, Surrey, United Kingdom, KT24 6QT
	The Crouch Oak Practice, 45 Station Road, Addlestone
	Addlestone, Surrey, United Kingdom, KT15 2BH

United Kingdom, Warwickshire
	Bridge House Medical Centre, Scholars Lane
	Stratford-upon-avon, Warwickshire, United Kingdom, CV37 6HE

United Kingdom, West Sussex
	Pound Hill Surgery, 1 Crawley Lane, Pound Hill
	Crawley, West Sussex, United Kingdom, RH10 7DX

Sponsors and Collaborators

Procter and Gamble

Investigators


Study Director:	John Beary, MD	Procter and Gamble

More Information

Publications indexed to this study:

Krzeski P, Buckland-Wright C, Bálint G, Cline GA, Stoner K, Lyon R, Beary J, Aronstein WS, Spector TD. Development of musculoskeletal toxicity without clear benefit after administration of PG-116800, a matrix metalloproteinase inhibitor, to patients with knee osteoarthritis: a randomized, 12-month, double-blind, placebo-controlled study. Arthritis Res Ther. 2007;9(5):R109.

Responsible Party:	Procter and Gamble Pharmaceuticals ( John Beary, MD )
Study ID Numbers:	2001065
First Received:	July 16, 2002
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00041756
Health Authority:	United States: Food and Drug Administration

Keywords provided by Procter and Gamble:

Primary Disease: Knee Primary Osteoarthritis

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00041756